NCT03838900|Completed
The Loop Observational Study
LOS
An Observational Study of Individuals With Type 1 Diabetes Using the Loop System for Automated Insulin Delivery
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LOS
An Observational Study of Individuals With Type 1 Diabetes Using the Loop System for Automated Insulin Delivery
Sponsor study identifier
observational
1,212
1 country
1
Study Start
January 17, 2019
Actual (reported)Primary Completion
March 31, 2020
Actual (reported)Study Completion
April 25, 2020
Actual (reported)An observational study to collect data on the efficacy, safety, usability, and quality of life/psychosocial effects of the Loop DIY automated insulin delivery system.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 25, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 21, 2018
Actual (reported)January 17, 2019
Actual (reported)February 12, 2019
Actual (reported)March 31, 2020
Actual (reported)April 25, 2020
Actual (reported)Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
Number of DKA events and event outcomes on the Adverse Event and Device Issue - Loop survey. DKA events are defined as the development of ketones with a diagnosis of DKA by a medical provider.
6 Months
Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
Number of severe hypoglycemic events and event outcomes on the Adverse Event and Device Issue - Loop survey. Severe hypoglycemia is defined as low blood sugar that affected the individual's ability to think such that they were unable to treat themselves and needed assistance from someone else. The individual may or may not have lost consciousness.
6 Months
Measure of Loop Safety by Self-Report of Hospitalization Events
Number of hospitalizations and event outcomes on the Adverse Event and Device Issue - Loop survey.
6 Months
Measure of Loop Safety by Self-Report of Diabetic Ketoacidosis (DKA) Events
12 Months
Measure of Loop Safety by Self-Report of Severe Hypoglycemic Events
12 Months
Measure of Loop Safety by Self-Report of Hospitalization Events
12 Months
Loop Baseline General Data Collection
Enrollment
Summary statistics for CGM metrics
6 months and 12 months
Loop Additional Form for Current Loop Users
Enrollment (cohort B), 3 Months (cohort A), 6 Months, and 12 Months
Individuals who have not started Loop or who have been on Loop fewer than 7 days at the time of enrollment.
Participants who have been using Loop 7 or more days at the time of enrollment.
The Loop System consists of an insulin pump (certain versions of Medtronic insulin pumps) and a Dexcom or Medtronic CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Individuals using or planning to use the Loop system
Jaeb Center for Health Research
Tampa, Florida, 33647, United States
Suttiratana SC, Wong JJ, Lanning MS, Dunlap A, Hanes SJ, Hood KK, Lal RA, Naranjo D. Qualitative Study of User Experiences with Loop, an Open-Source Automated Insulin Delivery System. Diabetes Technol Ther. 2022 Jun;24(6):416-423. doi: 10.1089/dia.2021.0485. Epub 2022 May 12.
Wong JJ, Suttiratana SC, Lal RA, Lum JW, Lanning MS, Dunlap A, Arbiter B, Hanes SJ, Bailey RJ, Hood KK, Naranjo D. Discontinued Use of the Loop Insulin Dosing System: A Mixed-Methods Investigation. Diabetes Technol Ther. 2022 Apr;24(4):241-248. doi: 10.1089/dia.2021.0362.
John Lum, MS
Jaeb Center for Health Research
1,212 participants (actual enrollment reported by the registry).
First Submitted
November 21, 2018
First Posted
February 12, 2019
Study Start
January 17, 2019
Actual (reported)Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2020
Actual (reported)Study Completion
April 25, 2020
Actual (reported)Last Updated
August 14, 2020
Record last verified: 2020-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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